Valve for controllable release of entrapped body fluids

ABSTRACT

A valve for controllably releasing entrapped body fluids, such as fluid from inside the skull of persons suffering from hydrocephalus. The valve includes a diaphragm which tends to close a valve seat and prevent flow of such fluid, and mechanical means for moving said diaphragm so as to open the valve to flow. The mechanical means may comprise a projection on the diaphragm which is contactible by a flexible portion of the body of the valve.

United States Patent [1 1 Schulte Oct. 30, 1973 [54] VALVE FORCONTROLLABLE RELEASE 3,595,240 7/1971 Mishler 128/350 V 0F ENTRAPPEDBODY FLUIDS [76] Inventor: Rudolf R. Schulte, 5377 Overpass PrimaryExaminer-Robert Nilson Rd., Santa Barbara, Calif. 93105 Gordon Angus et[22] Filed: Jan. 24, 1972 21 Appl. No.: 220,248 [57] ABSTRACT A valvefor controllably releasing entrapped body flu- [52] Cl 137/522 128,350 v137/525 ids, such as fluid from inside the skull of persons suf- 251/331fering from hydrocephalus. The valve includes a dia- 51 Int. Cl Fl6k15/14 A6lm 27/00 Which ends a and Prev 58 Field of Search 137/525 5225253- such-fluid and mechanical means mmng i 128/350 said diaphragm so asto open the valve to flow. The mechanical means may comprise aprojection on the [56] References Cited diaphragm which is contactibleby a flexible portion of UNITED STATES PATENTS the the 3,111,125 11/1963Schulte 128/350 V 17 Claims, 9 Drawing Figures PATENTED nm 3 0 ms SHEET2 OF 2 II II VALVE FOR CONTROLLABLE RELEASE OF ENTRAPPED BODY FLUIDSThis invention relates to valves for the controllable release ofentrapped body fluids.

Certain ailments of the human body involve the failure of the bodyproperly to drain fluids from its cavities. A well-known example of suchan ailment is hydrocephalus, wherein the cerebrospinal fluid is notdrained at the correct rate from the brain, and, as a consequence, thehead is distended and the persons brain is adversely affected. A

Means have heretofore been'provided to shunt the cerebrospinal fluidfrom the cranium, and such means are also useful in other regions of thebody as well. A classical example is shown in Schulte U.S. Pat. No.

3,111,125, issued Nov. 19, 1963, entitled Drainage Device, wherein acombined pump and check valve is disposed between a drainage catheterwhich is inserted into the cranium and a shunt tube with a check valvewhich customarily discharges into the heart.

The aforesaid shunting techniques and mechanisms have served theirpurpose very well, and many persons are alive and normal today whootherwise would long ago have been dead, or have been mentally retardedif they had survived. As the years have passed since the inauguration ofthis technique, the alleviation of the immediate problems has enableddevelopment to refine the technique so as to encourage the body tocorrect itself. One of the problems involved in the presentlyknown meansfor drainage is that the body may no longer attempt to overcome itsmalfunction, and instead the person will become reliant upon the shuntfor the rest of his life. It is an object of this invention to provide ashunt technique and device which in many cases may be expected torelease the person from dependency on a shunt. 7

One of the reasons which is currently postulated for the continuingdependency of a person upon his shunt is that perhaps too much of thefluid is drained, and the pressure'lowered too much. If, instead, morepressure were maintained in the cranium, there might be a tendency forthe drainage .passages later to open up. If so, then the personsdependency on the shunt might be overcome. is, therefore, theorized thatit would be advantageous to maintain a relatively high pressure in thecranium, but,'of course, this pressure must be such that the personwould not be harmed or made miserable by it. In approaching thisobjective, a valve can be provided which will tend to open at a givenpressure. Suppose, however, that this pressure proved to be too high forthe individual to tolerate for extended periods of time; then meansshould be provided for opening the valve so as to release the excessivepressure and relieve him. Such a valve thereby becomes a humane means ofretaining pressure at some relatively high level, but able to releasefluid to achieve a'lower pressure level should the greater pressurebecome intolerable.

A valve according to this invention comprises a body having an innersurface bounding a flow cavity. The body has a flexible portion whichcan be moved into the cavity. A first and a second conduit enter thecavity 7 through the body and provide for flow of fluid through thesame. A valve seat is provided in the cavity, across which seat fluidmust pass when flowing from one conduit to the other. A diaphragmextends across the cavity. It has an imperforate portion overlaying thevalve seat and is so proportioned and arranged as to close the seat inone position. A projection on one of the inner wall and the diaphragm isso disposed and arranged as to be contacted by the other, thereby todisplace the diaphragm from the seat and to permit fluid to flow acrossthe seat.

' According to a preferred but optional feature of the invention, theprojection is integral with the diaphragm and forms an oblique leverrelative to the plane of the valve seat.

According to another preferred but optional feature of the invention, abarrier extends across the cavity, the valve seat being formed on thebarrier with a flow port passing through the barrier within the valveseat. The diaphragm lies on one side of the barrier adjacent to thevalve seat, and the projection passes through'the flow port, having across-section less that that of the flow port.

The above and other features of this invention will be fully understoodfrom the following detailed description and the accompanying drawings inwhich:

FIG. 1 is an axial cross-section showing the presently preferredembodiment of the invention;

FIG. 2'is a partial view as in FIG. 1 showing the system in anotheroperating condition;

FIG. 3 is a plan view of part of FIG. 1 taken at line 33 of FIG. 1; 1

FIGS. 4, 5 and 6 are axial cross-sections of another embodiment of theinvention in various operating positions thereof;

FIG. 7 is an axial cross-section of still another embodiment of theinvention;

FIG. 8 is a top view of FIG. 5 taken at line 88 therein; and

FIG. 9 is an axial cross-section of still another embodiment of theinvention.

Valve 10 according to the invention is intended to drain cerebrospinalfluid from brain 11 which lies within a skull 12 that is overlaid by ascalp 13. In accordance with conventional practice, the valve has beenlaid under the scalp and the scalp has been sutured in place. I Y

A burr hole 14 has been drilled through the skull, and a drainagecatheter 15 has been inserted into the brain to collect the fluid to beremoved from the'skull. The drainage catheter joins to the valve at aconnector 16. A shunt tube 17, of the type generally shown in Heyer U.S.Pat. No. 3,020,913, issued Feb. 13 1962, entitled Surgical Drain, whichincludes a check valve in the squeeze the lozenge for. purposes yet tobe disclosed.

1 form of a slit at its free end, is attached by connector 18 to alozenge 19. The lozenge has a base 20 and a flexible dome 200, which canbe depressed so as to The shunt tube connects to the valve through thislozenge. i Y

Valve 10 includes a body 21 havinga flat base 22 to which there isattached a dome-shaped, flexible portion 23 which, with the flat base,forms an internal flow cavity 24. A first conduit 25 and a secondconduit 26 enter the cavity, conduit 25 being the upstream conduit, andconduit 26 being the downstream conduit. Drainage through the valve isfrom the drainage catheter through conduit 25, the flow cavity 24,conduit 26, lozenge l9, and shunt tube 17, in that order.

A barrier 30 extends across the flow cavity so as to divide the cavityinto two sections. This barrier is stiffly flexible and tends to retainits shape except under relatively strong force. A valve seat 31 isformed on the lower surface of the barrier, and a flow port 32 passesthrough the barrier inside the valve seat.

A diaphragm 33 also extends across the cavity and includes animperforate portion 34 near its center which is so proportioned as tooverlay the valve seat and to close it in the position shown in FIG. 1.Perforations 35 pass thorugh the diaphragm in regions outside theimperforate portion 34.

A projection 36 is integral with the diaphragm and passes thorugh theflow port. Its cross-section is less than that of the flow port so thatfluid can pass through the flow port even when the projection standsinside it.

On the inner surface of the flexible portion there is provided a contactportion 37. This portion is a cruciform structure with a central nib 38and ribs 39 which form bypass channels 37a. When the flexible portion ispressed down against the barrier, these channels will still permit fluidto flow into the flow channel.

This valve, as is the case in the other embodiments hereof, ispreferably made of medical grade silicone rubber. The desired stiffnessof the various items can be developed by appropriate selection of thethickness and physical properties of the material. The entireconstruction can be bonded together by suitable adhesives, such asroom-temperature vulcanizing medical grade silicone rubber. In anyevent, the materials which will come into contact with tissue will beselected for compatibility therewith.

The diaphragm will have sufficient inherent structural strength in thesense of rigidity or stiffness so that it will tend to resist itsdisplacement from the position shown in FIG. 1. If desired, bias meanssuch as a spring may be placed beneath it to assist this tendency.Usually, however, the stiffness of a properly selected diaphragm will besufficient for the purpose. The barrier should be relatively stiff so asto hold the valve seat in place relative to the base, although not-sostiff as to be immovable and constitute a possible risk of damage toother parts of the valve when the valve is compressed. The flexibleportion of the body should be readily'deflectible by application of thethumb to the scalp. Suitable dimensions for this device will be readilyapparent to persons skilled in'the art. V

Another embodiment of the invention is shown in FIGS. 4, 5, 6 and 8,wherein a valve includes a body 46 with a flange 47 to aid in thestabilization of the device in situ. It, too, has a base 48, and aflexible portion 49 attached to the base so as to form a flow cavity 50inside the body. A valve seat 51 is formed on the base, and thisvalveseat, as is true of the other valve seats in all of the embodimentsdisclosed herein, is circular, with its edge lying in a plane. Y

Inlet (first) conduit 52 passes through the base and enters the flowcavity inside the valve seat. Outlet (second) conduit 53 passes throughthe wall on the other side of a diaphragm 54. The diaphragm has acentral imperforate portion 55 which overlays and closes the valve seatas before. It also has perforations 56 therethrough outside theimperforate portion. Projection 57 is integral with the diaphragm andprojects therefrom at an angle oblique to the plane of the valve seat soas to form an oblique lever. Downward force on the projection isintended to open the valve seat, as will be more fully described below.

In accordance with the invention, -a check valve 58, such as shunt tube17, may be connected to the outlet conduit if desired.

FIG. 7 shows another embodiment of the invention wherein a valve 60includes a base 61, dome-shaped, flexible portion 62, flow cavity 63,inlet (first) and outlet (second) conduits 64, 65. A barrier 66 extendsacross the cavity and carries a valve seat 67, there being a flow port68 through the barrier within the valve seat.

A diaphragm 69 also extends across the cavity, having a centralimperforate portion 70, with perforations 71 therethrough outsideportion 70. The primary difference between the embodiment of FIGS. 4 and7 is that,'in FIG. 4, the base is curved so as to fit in a burr hole inthe skull, while in FIG. 7, the device is flat so as to fit against theskull as in FIG. 1. Another difference resides in projection 72 whichcarries a head 73 contactible by the flexible portion.

FIG. 9 is another flat-bottomed embodiment of the invention andrepresents a modification of the device of FIG. 4. In this embodiment,the body 74 of valve 75 has a flat base 76, and a domeshaped flexibleportion 77 forming a flow cavity 78. A diaphragm 79 extends across thecavity and includes a central imperforate portion 80 with perforations81 outside the imperforate region. An inlet (first) conduit 82 and anoutlet (second) conduit 83 enter the flow cavity on opposite sides ofthe valve seat so that in this, as in the other embodiments of theinvention, fluid flow must pass across the valve seat in order to flowthrough the cavity. A projection 84 is integral with the diaphragm andextends to form an oblique lever relative to the plane of the seat.

The operation of the valves should be evident from the foregoing. InFIG. 1, the device is shown in its closed position wherein upstreampressure is not yet sufficient to overcome and open the diaphragm, andthere is no physical pressure applied through the flexible portion toopen the valve. In this condition, the diaphragm bears against the valveseat and keeps the valve closed. Fluid is retained in the skull atapressure inherently determined by the valve itself. Should the pressureexceed this level, the diaphragm will move off the seat to relieve it.

Assume now that the pressure determined by the valve is too great forthe person to tolerate. Then a force illustrated by arrow 85 in FIG. 2will be applied through the scalp and against the flexible portion so asto deflect the flexible portion downward into the cavity so that thecontact portion 37 presses against projection 36 and displaces thediaphragm away from the valve seat. Now, fluid will drain through thebypass channels, through the flow port, across the valve seat,

, and out the valve. The valve will remain open to flow until force 85is removed. Bypass channels 37a assure that flow port 32 will not beclosed by the flexible portion when it is pressed against barrier 30.

The lozenge 19 is provided for various purposes of testing andinjection. Should injection of a fluid into the brain be desired, it maybe injected from a syringe whose needle is pressed through the wall ofthe lozenge, while the downstream shunt is pinched closed by externalpressure and the valve is held open as shown in FIG. 2. This will causethe medication to flow back into the brain. This lozenge can also beutilized to clear any obstructions in the shunt tube because, if it ispressed while the valve itself is not mechanically held open, pressuregenerated by the lozenge will tend only to close the valve more tightly,while it will tend to expel fluid downstream, thereby clearing the checkvalve. It will thereby be noted that this valve also acts as aunidirectional check valve which, however, is subject to being opened bycontact with the projection.

FIG. 1 also illustrates that the prjection may be considered to be onthe flexible portion of the body instead of on the'diaphragm because, ofcourse, the nib 38 may be of any desired length and may, if desired,make direct contact with the diaphragm. In this sense it is sometimesreferred to as a projection, and it is clear that a projection whichenables the flexible portion and the diaphragm to make contact with oneanother can be mounted either to the diaphragm or to the flexibleportion, andthat in every case the projection will be regarded as anextension of one or the other, whereby the flexible portion and thediaphragm may be considered so disposed and arranged as to be contactedby the other in order to displace the diaphragm from the seat and topermit fluid to flow across the seat. The same relationship iscomprehended should the projection be provided as a separate piece.Also, although it is not desirable to have loose pieces in a system suchas this, it may be a free section of rod trapped in the flow port. Theprojection may be formed on the diaphragm and flexible portion, ifdesired. However, the projection, when attached to the diaphragm,appears to give stability to the diaphragm because of the available sidesupport from the walls of the-flow port.

The functioning of the other embodiments is similar, except that, in theembodiments of FIGS. 4 and 9, a tilting action takes place instead ofthe axial displacement of FIGS. 1 and 7. In both cases, the diaphragmwill be displaced by sufficient fluid pressure.

In FIG. 4, the valve is shown in its normally closed position due to theinherent structural properties of the diaphragm itself, i.e., thestiffness or rigidity of the diaphragm. In the event that upstreampressure becomes sufficiently large, then the condition shown in FIG. 5occurs wherein the diaphragm will lift up to relieve the excesspressure. In the event that positive drainage is flexible portion isreleased, the diaphragm will'return to its normal position as in FIG. 4.In this, as in all embodiments, the lozenge may be placed downstream, aswell as a check valve.

The operation of the valve of FIG. 9 is the same as that just describedfor FIG. 4. v

In the case of the valve of FIG. 7, its operation is the same as that ofFIG. 1, downward deflectionof the flexible portion pressing against theenlargement on the projection'and forcing the diaphragm away fromtheseatto open the flow port.

The perforations in the diaphragms are variously provided as flowchannels or and for equalization of pressure on opposite sides inregions outside the valve seat,

This invention is not to be limited by the embodiments shown in thedrawings and described in the description, which are given by way ofexample and not of limitation, but only in accordance with the scope ofthe appended claims.

I claim:

1. A valve for controllably releasing entrapped body fluids, comprising:a body having an inner surface bounding a flow cavity therein, said bodyhaving a flexible portion which can be deflected into the cavity; afirst and a second conduit entering said cavity through said body toprovide for flow of fluid through the cavity; a valve seat in saidcavity across which fluid must flow when flowing from one conduit to theother; a diaphragm extending across the cavity and having an imperforateportion overlaying the valve seat and so proportioned and arranged as toclose the same in one position of the said imperforate portion and toleave it open in another position; and a projection on one of saidflexible portion and diaphragm so disposed and arranged as to becontacted by the other, thereby to displace the diaphragm from the seatand permit fluid to flow across said seat.

2. A valve according to claim 1 inwhich the-diaphragm is perforatedoutside the said imperforate re-.

gion, whereby when the imperforate portion of the diaphragm is seated onthe valve seat, its opposite sides are exposed to the pressure ofrespective ones of said conduits.

3. A valve according to claim 1 in which the valve seat is formed onsaid inner surface, with one of the conduits passing through the bodyinside said seat, the seat lying in a plane, and in which the projectionis integral with the diaphragm and forms an oblique lever relative tosaid plane, whereby pressing the said flexible portion of the bodyagainst the projection tilts the diaphragm so as to interrupt its sealwith the valve seat.

4. A valve according to claim 3 in which the exterior portion of thebody on which the valve seat lies is flat.

5. A valve according to claim 1 in which a barrier extends across thecavity, the valve seat being formed on said barrier with a flowport'passing through the barrier within the valve seat, the diaphragmlying on one side of said barrier adjacent to said valveseat, and theprojection being proportionedso as to enter the flow port in at leastone position of the valve and having a crosssection less than that ofsaid flow port so as to permit flow of fluid past it. i

6. A valve according to claim 5 in which the projection is mounted totheflexible portion of the body.

1 7. A valve according to claim 5 in which the projection is mounted tothe'diaphragm.

' 8. A valve according to claim 7 in which a contact portion is mountedto the flexible portion to make contact with the projection, saidcontact portion forming bypass channels to form flow passages to theflow port when the contact portion is pressed against the barrier.

9. A valve according to claim 7 in which an enlargement is formed on theprojection on the side of the barrier away from the diaphragm.

10. A valveaccording to claim 7 in which the outer surface of thatportion of the body on the opposite side of the cavity from the flexibleportion is flat.

11. A valve according to claim 10 in which a contact portion is mountedto the flexible portion to make contact with the projection, saidcontact portion forming bypass channels to form flow passages to theflow port when the contact portion is pressed against the barrier.

12. A valve according to claim 1 in which the diaphragm has an inherentstructural strength tending to bias the imperforate portion toward andagainst the valve seat.

13. A valve according to claim 3 in which the diaphragm has an inherentstructural strength tending to bias the imperforate portion toward andagainst the valve seat.

14. A valve according to claim 5 in which the diaphragm has an inherentstructural strength tending to bias the imperforate portion toward andagainst the valve seat.

15. A valve according to claim 8 in which the diaphragm has an inherentstructural strength tending to bias the imperforate portion toward andagainst the valve seat.

16. A valve according to claim 1 in which a lozenge having a cavitydefined in part by a flexible wall portion, and having a pair ofconduits entering into its cavity is connected to the cavity of thevalve by means of a fluid connection between one of its conduits, andthe conduit in the valve from which fluid flows after being released bydisplacement of the diaphragm from the valve seat.

17. A valve according to claim 1 in which a unidirectional check valveis fluidly connected to the conduit from which fluid flows after beingreleased by displacement of the diaphragm from the valve seat.

1. A valve for controllably releasing entrapped body fluids, comprising:a body having an inner surface bounding a flow cavity therein, said bodyhaving a flexible portion which can be deflected into the cavity; afirst and a second conduit entering said cavity through said body toprovide for flow of fluid through the cavity; a valve seat in saidcavity across which fluid must flow when flowing from one conduit to theother; a diaphragm extending across the cavity and having an imperforateportion overlaying the valve seat and so proportioned and arranged as toclose the same in one position of the said imperforate portion and toleave it open in another position; and a projection on one of saidflexible portion and diaphragm so disposed and arranged as to becontacted by the other, thereby to displace the diaphragm from the seatand permit fluid to flow across said seat.
 2. A valve according to claim1 in which the diaphragm is perforated outside the said imperforateregion, whereby when the imperforate portion of the diaphragm is seatedon the valve seat, its opposite sides are exposed to the pressure ofrespective ones of said conduits.
 3. A valve according to claim 1 inwhich the valve seat is formed on said inner surface, with one of theconduits passing through the body inside said seat, the seat lying in aplane, and in which the projection is integral with the diaphragm andforms an oblique Lever relative to said plane, whereby pressing the saidflexible portion of the body against the projection tilts the diaphragmso as to interrupt its seal with the valve seat.
 4. A valve according toclaim 3 in which the exterior portion of the body on which the valveseat lies is flat.
 5. A valve according to claim 1 in which a barrierextends across the cavity, the valve seat being formed on said barrierwith a flow port passing through the barrier within the valve seat, thediaphragm lying on one side of said barrier adjacent to said valve seat,and the projection being proportioned so as to enter the flow port in atleast one position of the valve and having a cross-section less thanthat of said flow port so as to permit flow of fluid past it.
 6. A valveaccording to claim 5 in which the projection is mounted to the flexibleportion of the body.
 7. A valve according to claim 5 in which theprojection is mounted to the diaphragm.
 8. A valve according to claim 7in which a contact portion is mounted to the flexible portion to makecontact with the projection, said contact portion forming bypasschannels to form flow passages to the flow port when the contact portionis pressed against the barrier.
 9. A valve according to claim 7 in whichan enlargement is formed on the projection on the side of the barrieraway from the diaphragm.
 10. A valve according to claim 7 in which theouter surface of that portion of the body on the opposite side of thecavity from the flexible portion is flat.
 11. A valve according to claim10 in which a contact portion is mounted to the flexible portion to makecontact with the projection, said contact portion forming bypasschannels to form flow passages to the flow port when the contact portionis pressed against the barrier.
 12. A valve according to claim 1 inwhich the diaphragm has an inherent structural strength tending to biasthe imperforate portion toward and against the valve seat.
 13. A valveaccording to claim 3 in which the diaphragm has an inherent structuralstrength tending to bias the imperforate portion toward and against thevalve seat.
 14. A valve according to claim 5 in which the diaphragm hasan inherent structural strength tending to bias the imperforate portiontoward and against the valve seat.
 15. A valve according to claim 8 inwhich the diaphragm has an inherent structural strength tending to biasthe imperforate portion toward and against the valve seat.
 16. A valveaccording to claim 1 in which a lozenge having a cavity defined in partby a flexible wall portion, and having a pair of conduits entering intoits cavity is connected to the cavity of the valve by means of a fluidconnection between one of its conduits, and the conduit in the valvefrom which fluid flows after being released by displacement of thediaphragm from the valve seat.
 17. A valve according to claim 1 in whicha unidirectional check valve is fluidly connected to the conduit fromwhich fluid flows after being released by displacement of the diaphragmfrom the valve seat.